The Recall Desk
HighFDA (Devices)·Z-0038-2024·Announced 2023-10-11

AB Sciex 4500MD Triple Quad Mass Spectrometer Recall Due to Fire Risk

AB Sciex has recalled 38 units of the 4500MD Triple Quad Mass Spectrometer nationwide due to a rare risk of flame and electrode ejection from solvent leaks combined with electrical discharge.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This product presents a risk of harm (flame and property damage) but no illnesses or injuries have been reported. Per the severity rubric, risk-of-harm products where injury has not been reported score 3 (High).

Plain-English summary

AB Sciex, LLC is recalling 38 units of the 4500MD Triple Quad Mass Spectrometer (Part Number 5032522) distributed nationwide in the United States.

In rare circumstances, a leak of highly flammable solvent at the ion source probe combined with an electrical discharge may ignite a flame on top of the probe. This could result in the ejection of the electrode assembly. The flame poses a risk to operators, patients, customer property, and the environment if left unattended.

Additionally, the failure may delay patient test results. This recall was initiated due to the potential for health risk and property damage.

The recalled product

Product
4500MD Triple Quad Mass Spectrometer, Part Number 5032522
Manufacturer
AB Sciex, LLC
Category
Medical Device — Laboratory / Diagnostic Equipment
Hazard
Affected units
38

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • UDI-DI: 00842365102049
  • Serial Numbers: EJ230051806PL
  • EJ230061807PL
  • EJ230071808
  • EJ230101810
  • EJ230111811
  • EJ230121811
  • EJ230141811
  • EJ230151812
  • EJ230161812
  • EJ230171901
  • EJ230181901
  • EJ230191901
  • EJ230211905
  • EJ230221908
  • EJ230231908
  • EJ230251909
  • EJ230271910
  • EJ230281910
  • EJ230311911

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by AB Sciex, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Related recalls

Same manufacturer · AB Sciex, LLC

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Same hazard · fire

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